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news.Alfacell and Novartis to collaborate over dengue fever drug
Dengue fever is a mosquito-borne viral infection, causing fever and severe joint pain, hemorrhage and shock in some cases and, in the most severe cases, death. The World
Dengue fever is a mosquito-borne viral infection, causing fever and severe joint pain, hemorrhage and shock in some cases and, in the most severe cases, death. The World
The FDA request is in response to an investigational new drug application (IND) filed by the company in May 2005. “We appreciate the FDA’s consideration in carefully reviewing
The study will monitor the effects of the drug on patients with malignant pleural effusion or ascites, which are conditions related to malignant tumors, and characterized by the
PV-10, which is designed to be retained in tumor cells while leaving normal tissue unharmed, will be injected into one to three tumors in each subject. The local
Under the agreement, Peregrine will supply Tarvacin, its lead anti-phospholipid therapy agent, for in vitro and in vivo animal studies developed by the US Army Medical Research Institute
The study is scheduled to enroll up to 112 healthy volunteers, and will follow a dose escalation program that is designed to determine the safety and tolerability of
The acquisition will also strengthen MGI Pharma’s position in the acute-care drugs market. In particular, MGI will gain access to Guilford’s Gliadel Wafer brain cancer treatment and the
As part of the APT-funded program, Aradigm will source the active pharmaceutical ingredient, conduct the formulation development of the drug product, manufacture clinical supplies and execute regulatory and
Patients received either placebo or PreHistin during a six week trial; three weeks were administered prior to the onset of the allergy season, and patients were studied for
BDSI filed the new drug application (NDA) in late April 2005, and this written notification indicates that the FDA review of the product is now underway. The FDA